NCT05961852
Completed
Phase 1
COmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis (CONCERTO)
ConditionsArteriovenous Fistula Stenosis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Arteriovenous Fistula Stenosis
- Sponsor
- Singapore General Hospital
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Target lesion primary patency
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
To evaluate the preliminary efficacy of combination of cutting and drug-coated balloon for the treatment of resistant AVF stenosis.
Detailed Description
This is a single arm pilot study recruiting 19 participants with resistant AVF stenosis (defined as having \> 30% residual stenosis after optimal balloon angioplasty) to receive cutting and drug-coated balloon. The outcome measure is target lesion primary patency at 6 months. Outcome will be clinically driven.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Failing mature upper limb AVF
- •Resistant stenosis (\>30% residual stenosis) after optimal conventional balloon angioplasty (appropriately sized balloon, inflated up to rated burst pressure, at least twice for at least a minute per inflation)
- •Patient is \>= 21 years of age
- •Ability to provide informed consent
Exclusion Criteria
- •Thrombosed AVF
- •Target lesion has a sharp angle (\> 45 degrees)
- •Lesions requiring cutting balloon size \> 7 mm
- •Coagulopathy or thrombocytopaenia that cannot be adequately managed for the procedure
- •Contraindication to dual antiplatelet therapy
- •Severe allergy to contrast media that cannot be adequately managed for the procedure
- •Breast-feeding and/or pregnant females
- •Male patients who are planning to father children during the trial period
- •Unable to comply with follow up protocol (for instance, limited life expectancy)
Outcomes
Primary Outcomes
Target lesion primary patency
Time Frame: 6 months after index procedure
Time from index treatment to repeat treatment of target lesion or thrombosis of circuit.
Study Sites (1)
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